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Ethics

Clinical Studies (2nd part)

Importance of clinical studies

The clinical trial is the only way to improve the knowledge of a pathology and its treatment. It permits to show the harmlessness and the effectiveness of the treatments. Before including a new treatment in the normal course of events, it is essential to prove its harmlessness and its superiority to other existing reference treatments. The studies are carried out with voluntary patients.
Therefore, the clinical trial favours medical advances, which brings well-being.
New cancer treatments will be administered only if they have proved their validity within strict clinical studies. So, advances in cancer treatment necessarily go through clinical research.

 

Potential advantages in taking part in a clinical study :

- the potential access to new medicine treatments, sometimes before their markeing;
- a strict medical aftercare led by a multidisciplinary and often international team;
- having a more active role in the therapeutic approach;
- contributing to the research effort, which will improve therapies and medical aid for other patients.

Each study has its own protocol and the patient has to meet the requirements of eligibility to take part in it. The patients are included in the study according to the type of cancer they suffer from, the stage of the pathology, and possibly according to their age, sex, previous treatments or other factors specific to the patient or the pathology.

Potential disadvantages in taking part in a clinical study :
- as the clinical trials include research on medical issues, there are always relative doubts about the side effects caused by the treatment studied, and even about its effectiveness. The side effects vary from one patient to the next. Usually they are comparable to those observed with the reference treatment and, in most cases, they are temporary and disappear when the treatment is over.
- when a patient takes part in a clinical trial, he sometimes has to stop taking other medicines which could interfere with the effect of the treatment studied.
- taking part in a study also means accepting a protocol. This brings about obligations for the patient : he has to undergo medical examinations following a strict timetable and which rate is often faster than that of an ordinary medical aftercare, he has to fill in questionnaires or hold a diary.

 

What is important to ask ?

(Questions coming from "Les Etudes Cliniques" information booklet intended for the patient, published by the EORTC, European Organization for Research and Treatment of Cancer)
- What is the study aiming at ?
- Who is in charge of controlling and authorising the study ?
- What are the different kinds of tests and treatments ? Ask for information about the what and the how.
- What might occur to me with the new treatment ? And without? How will my cancer react and how am I going to react to the treatment ?
- How will the study have an influence on my daily life ?
- What are the side effects to be expected ? The reference treatment and the pathology can also cause side effects; ask which ones.
- How long will the study last? Is it likely to require additional time investment from me?
- Do I have to be hospitalised ? If so, how many times and for how long?
- Will my treatment costs be different ?
- If I have side effects, what are the treatments I am entitled to ?
- Which long term care is part of the study ?
- How are the data of the study and the patient's safety controlled ?
- Where does the information obtained in that way go to ? As far as the studies coordinated by the EORTC are concerned, the data are dispatched to an analysis centre where they are examined by doctors, statisticians and other scientists specialised in clinical research ?

 

Protection of the patient

Ethics Committee : A clinical trial or any clinical research necessarily requires the consent of the ethics commitee (Law of the 12/08/1994 published in the "Moniteur" of the 27/09/1994) of the hospital where the research, which structure is determined by the law, takes place.
The examination of the Ethics Committee checks the compliance of the project subject to the recommendations from "The Helsinki Declaration" and from "Good Clinical Practice ".
(Référence : "Good Clinical Practice", edited by Josef Kolman, Paul Meng, Graeme Scott. Ed Wiley-1998)

 

Informed consent :

It is essential that the research doctor and his team tell the patient the risks known and the potential advantages that the participation in a clinical trial involves.
It is essential to understand the study as well as possible, and to know how the treatments and examinations received within the context of the study can be different from the alternatives available outside the study. The doctor has to give the patient a document in which the risks and the results hoped will be explained.
The patient must never hesitate to ask questions. When he thinks that the information received is sufficient and when he chooses to participate in the study, he has to notify it on a form called "informed consent". He will also be given the phone number of a member of the research team in order to receive additional information.
The decision to participate is purely voluntary. It is absolutely acceptable to decide not to participate, even if the doctor and the researcher team took time to explain the study. That person will be given the best treatments applied outside the study and all the care of the health personnel.
Confidentiality of the data :
The research doctor of the study has to check that all the precautions have been taken to guarantee the confidentiality of the patient's identity. In most cases, the initials and the date of birth only appear in the documents of the study, and the patients are identified by a special number used in the context of the study only.
How can you leave a study ?
As he can refuse a treatment, a patient can decide to leave the study in which he had started to participate at any time.

 

Links with other web sites :

www.cancer.gov/clinical_trials/

1st Part : click here
• Definition
• Clinical trials are classified in four categories or phases
• How does a clinical trial work ?